Aortic valve no exchange catheter

ABSTRACT

A medical device and use thereof provide percutaneous access to a targeted site within a living body, for example the left ventricle of the heart. The device includes an inner tubular member, outer tubular member, and an adjustable control handle. The control handle can precisely control the relative position of the inner tubular member relative to the outer member by providing feedback to the operator. This feedback provided by the control handle allows the operator to precisely maneuver the catheter within a body and change the shape of the catheter system without taking his/her eyes off the task that he/she is performing. The control handle is designed to precisely change the catheter system from one tip shape to another tip shape and back.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the priority date of U.S.Provisional Patent Application Ser. No. 62/469,624, titled AORTIC VALVENO EXCHANGE CATHETER, filed Mar. 10, 2017.

BACKGROUND Field

This present disclosure relates generally to the field of devices usedto gain vascular access to organs within a living body and, moreparticularly, to a concentric dual-member catheter device which allowsprecise positioning and tip shape change of a catheter used intranscatheter aortic valve replacement procedures while minimizingdistractions to the operator.

Discussion

While there are different methods to gain access to internal organs inthe body to perform a medical procedure, less invasive approaches usingcatheters and guidewires delivered through the body's vascular systemhave become widespread. Minimally invasive procedures offer improvedpatient outcomes, often with fewer complications and shorter recoveryperiods. Consequently, increasingly complex percutaneous interventionalprocedures have been developed to treat various diseases.

In treating heart disease, for example, the use of guidewires andcatheters has a long-established history of use. Initially, percutaneouscoronary interventions (PCI) were often directed at diagnosing andtreating blocked vessels within the heart. More recently, technologiesto treat structural heart disorders have been developed and are now partof an interventionalist's armamentarium. Interventional structural hearttechnologies are comparatively complicated devices requiring advancedtechniques to perform the procedure. For example, in TranscatheterAortic Valve Replacement (TAVR) procedures, a prosthetic valve mountedon a stent is delivered via a catheter, over a guidewire, for placementover a patient's native valve apparatus.

The TAVR procedure is indicated for patients with severe aortic stenosiswho may be intermediate or high risk for valve replacement surgery. Thenumber of TAVR procedures has grown rapidly, year over year, asphysicians and patients have chosen this minimally invasive approachover more traditional open chest, arrested heart procedures requiring abypass pump. In order to perform a TAVR procedure, the interventionalistmust first access the left ventricle.

Tools to gain access to the left ventricle exist, however, they are notideal. There are numerous steps needed in a TAVR procedure prior todelivering the replacement valve. Developing improved technologies tocombine needed steps can reduce procedural risks associated withmultiple device exchanges. These risks include perforation of the heartor vessels and introduction of emboli resulting in stroke. There areother potential complications. The advanced techniques and the highlevel of concentration required to successfully perform a TAVR procedurehighlights an unmet need to reduce device exchanges as much as possibleto shorten and simplify the procedure in order improve to patientoutcomes.

In improving intravascular procedures, Stevens (U.S. Pat. No. 3,503,385)discloses a vascular diagnostic catheter with an embedded control wire,spanning from the catheter tip to a proximal (near) handle. The controlmechanism attached to the handle then manipulates the distal (far) tipof the catheter to form different curves. While this solution enableschanging the shape of the distal end of a catheter, it is a costlysolution that reduces space efficiency because of the need to have pullwires and the required lumens in a catheter shaft to house the pullwires.

Wittes, et al. (U.S. Pat. No. 3,680,562) describes a catheter with aninwardly curved tip, like a pigtail, with a series of ports alignedlongitudinally. A hollow piercing member is inserted to straighten thecurved tip to facilitate delivery. There are other devices thatsimilarly change shape using a stiff insertable member into thecatheter. This device and others, which utilize a stiffening insert tochange the shape of the distal end of the catheter, add steps to theprocedure. The stiffening element must be inserted and withdrawn toachieve a shape change. In a complex procedure performed in a settingwith many distractions, there is a need for the operator to be able tomanipulate the catheter distal tip from an initial configuration to afinal configuration quickly and easily, without taking undue attentionand effort.

Pigtail shaped diagnostic catheters have long been used in intravascularmedical procedures. They can be used to infuse imaging agents or drainfluid from organs. In addition, the pigtail configuration can be used tosheath a guidewire, offering protection against injury caused by aguidewire. The curved pigtail shape can have multiple loops whichdeflect the guidewire away from vulnerable tissue. Pigtail catheters,however, are not ideally shaped to traverse the vasculature to reachhard to access areas in the body. Pigtail catheters must often beexchanged with other guiding catheters more suitably shaped to reach aprecise target location in the body. Making catheter exchanges oftenentails the need to exchange guidewires, further complicating theprocedure.

U.S. Pat. No. 4,033,331 describes the use of a wire to shape the tip ofa catheter. The wire, which fills the internal lumen of the catheter,then must be extended or retracted to change the shape of the distalend. This method of catheter tip shaping can involve many steps. Thereis a need for a device which more efficiently reduces the steps neededto perform a procedure.

U.S. Pat. No. 5,120,323 discloses a telescoping guide catheter systemcomprised of an inner and outer guide catheter, neither of which ispre-curved. US20070021732A1 describes an inner guiding introducer and anouter guiding introducer to access the left ventricle. Both the innerand outer members are pre-curved. However, both systems lack a means toprecisely control retraction and extension of the inner member relativeto the outer member.

U.S. Pat. No. 4,960,134A describes a catheter with a symmetricalcylindrical control handle and a flexible catheter tip. The controlhandle comprises a housing having a piston chamber. A piston is mountedin the piston chamber and can move lengthwise. The proximal end of thecatheter body is fixedly attached to the distal end of the piston. Apull wire is attached to the housing and extends through to the cathetertip. Lengthwise movement of the piston relative to the housing resultsin deflection of the catheter tip. While a control mechanism enablesprecise tip deflection, the use of pull wires through a catheter using adedicated lumen precludes a space efficient and cost effective solution.

U.S. Pat. No. 5,666,970A describes a control mechanism for manipulatingthe shape of the catheter and providing a rotational locking mechanism.This solution describes multiple moving elements, including a biasingmember to control catheter movement. This complex solution requires alarge housing, which makes it impractical to miniaturize and expensiveto manufacture.

In US20150119853A1, Gainor describes a convertible shape catheter andmethod of use that includes the use of two catheters designed to work intandem, one inside the other, to achieve any number of catheter distaltip shapes to advance through the anatomy and provide for a pigtailconfiguration. This unlimited range of adjustments becomes a hindrancein a procedure on a frail patient, where longer procedures areassociated with serious complications such as renal failure due to theexcessive use of imaging contrast and patient dehydration. For thisdesign, catheter manipulation to change from an initial to a finalorientation requires fluoroscopic visual guidance, with contrast mediainjections. This task may require a degree of operator concentration andextended manipulation that obviates any purported advantages.

In diagnosing and treating circulatory diseases it can be advantageousto measure differential pressure within a living body. For example, thedifferential pressure can be measured across the aortic valve toquantify the severity of the stenoses affecting blood flow from theheart to other organs.

There are intravascular catheter devices in the prior art that utilizethe means to make two pressure measurements to measure differentialpressure within a living body. Such prior art patents include U.S. Pat.Nos. 6,616,597B2, 7,229,403B2, 5,427,114A, 4,901,731A, 7,717,854B2.

In U.S. Pat. No. 4,777,951A, Cribier et al., taught the use of measuringdifferential pressure across the aortic valve using a balloon catheterto confirm diagnosis of calcified aortic valve stenosis and to treat thecondition via dilation of the valve orifice by inflating the balloonwithin the stenotic valve. The effect of the balloon inflations todilate the stenotic region could be measured by the pressure drop acrossthe aortic valve annulus, when measured from the left ventricle acrossthe obstructed valvular apparatus and into the aorta. This differentialpressure could be measured sequentially after successive ballooninflations to measure the effect of balloon dilation to achieve someendpoint that presumably relieves symptoms of the disease. Importantly,measuring differential pressure requires simultaneous pressure readingsfrom two areas such as between the left ventricle and the aorta. The useof a balloon to enlarge the aortic valve orifice, while still performed,has been largely supplanted by a catheter based approach to implant aprosthetic valve apparatus over the native valve. This new procedurewould benefit from a device better integrated into the workflow of thecurrently practiced procedure.

In U.S. Pat. No. 9,332,914B2, Langston proposed the use of a dual lumenpigtail catheter, one lumen placed in the left ventricle and the otherexposed to the aorta, to measure differential pressure across the aorticvalve to diagnose aortic valve stenosis. This device does not facilitatea seamless transition to a therapeutic transcatheter aortic valveprocedure, hence adding to a workflow that is already demanding of theoperator.

There remains an unmet need for a device to provide for differentialpressure measurements, or any two channel sensor measurements tointerrogate the circulatory system function, better optimized tofacilitate today's complex interventional procedures by eliminating orcombining steps in a difficult procedure requiring high levels ofconcentration routinely performed on frail patients.

The utilization of these prior art devices is compromised by size,complexity, difficulty of use, lack of utility and cost. In addition,handle control mechanisms current available offer a limited range ofmotion. Catheter handles offering steering capability also tend to belarge in diameter, compromising their utility. Consequently, thereremains a need for a device that can facilitate access to a preciselocation within the body, enable an easy and fast catheter shape change,and provide for measuring differential pressure within vasculatureacross an obstructed and diseased valve in a cost and space efficientmanner.

Other procedures are similarly compromised. Techniques currently used tofacilitate PCIs include the concept of a parent-child catheter, with aninner catheter being inserted through an outer guide catheter to provideadditional support in complex PCI procedures where a balloon or stentbacks out of the target position. In this case an inner catheter isinserted through a guide catheter to provide additional support.Currently, this parent-child catheter arrangement requires two separatecatheters. There is a need to simplify the procedure needed to provideadditional support during PCI procedures.

Another interventional procedure in need of improvement includes radialartery cardiac catheterization. This technique is increasing in use andthere is a need for specialized radial catheters to improve the workflowand procedure. One of the keys for radial catheterization is to reducethe number of catheter exchanges in order to reduce radial artery spasm.Currently there exists single catheters for this procedure, but theyhave very aggressive shapes, wildly contoured at the tips, that couldpotentially lead to dissection of the coronary vessel.

SUMMARY

The disclosed invention provides for a time saving medical device foruse in medical procedures, such as transcatheter valve replacements,that offers a combination of features which reduces the number ofmedical devices needed to perform the procedure while offering bothdiagnostic function and procedure time savings in seamlesslytransitioning from a diagnostic procedure to a therapeutic procedure.Another advantage of this invention is that the patient and labpersonnel will be exposed to less radiation. This will also have thepotential to make the procedure safer. This device offers to save thehealthcare system costs associated with the use of extra devices and thetime needed to perform numerous device exchanges now required to safelyperform a procedure, such as a TAVR procedure.

The invention is a catheter system comprised of an inner and an outertubular member with an attached control handle mechanism. The innertubular member and outer tubular member are also referred to as theinner and outer catheters. The outer tubular member can be advanced orretracted relative to the inner tubular member, the advancement orretraction controlled by a control handle mechanism. The inner and outertubular member are pre-curved or, in other words, processed into anon-linear shape. It is also anticipated that one or more of thecatheters can be straight and still benefit from this invention. Thecontrol handle is designed to provide precise and repeatable movement ofthe outer tubular member relative to the inner tubular member. Thispermits easy changes in catheter form minimizing the effort needed bythe operator to make device changes while performing the procedure.

The inner tubular member has the resilience to adapt to the pre-curvedshape of the outer tubular member when the outer tubular member isextended over the distal tip of the inner tubular member. This shapechange feature facilitates safe and easy access to a treatment site,providing for an initial configuration optimized to access the treatmentsite and a second configuration optimized for use at the treatment site.This system is designed to eliminate a catheter exchange and the needfor multiple guidewire exchanges used to facilitate catheter exchanges.

The device includes a relatively long inner tubular member as comparedwith the outer tubular member. The outer tubular member can be extendedcompletely over the distal tip of the inner tubular member. The outertubular member is constructed with a stiffness that conforms the shapeof the inner tubular member to that of the outer tubular member. Thedistal end of the outer tubular member is shaped to optimize access tothe left ventricle or another target site. A control handle enablesprecise and repeatable movement of the outer tubular member resulting ina shape change from an initial tip shape configuration to a final tipshape configuration, by exposing the inner tubular member withoutdistraction or undue manipulation. This is accomplished by permitting adefined range of travel that is governed by a distal stop, a movablerange and a proximal stop. This predefined range of motion enables theoperator to make tip shape changes easily and without the need forfluoroscopic visual confirmation and without the need for the operatorto visually observe the handle when making a change.

The invention may also be configured to deliver devices into other areasof the body, for example, into the left atrial chamber of the heartthrough a septal puncture, or into coronary arteries. More broadly, thisinvention can replace numerous devices needed to gain access to aspecific location in the anatomy. The position of the control handledistal stop, allowable range of motion, and proximal stop are adjustedto suit a specific application. It may also be advantageous to reversethe direction of the catheter system movement from retracting the outercatheter, or outer tubular member, to expose the inner catheter toextending an inner catheter past the end of the outer catheter.

The control handle precisely controls the shape change of the catheterin repeatable manner. The range of motion of the outer tubular member isconstrained. This is controlled by the allowable travel designed intothe handle. In limiting the range of relative positioning, the operatorcan easily facilitate a fast exchange, in a controlled manner, from aninitial configuration to a final configuration. A positive lock and/ordetent mechanism is incorporated into the control handle to secure thedevice in its intended configuration until the operator desires tochange the catheter distal shape. The handle control mechanism has beenoptimized to provide a long range of movement in a small space efficientpackage.

The outer tubular member may have a side port configured to fluidlycommunicate with the lumen of the outer tubular member. In this way, thelumen can be flushed with saline or other fluids. A vacuum can also beapplied through the side port to remove air or other gas bubbles fromthe lumen of the outer tubular member to prevent air ingress into theblood circulation system.

A pressure transducer or a separate port engaged with a pressuretransducer can be connected to the outer tubular member side port. Theside port described may have a threaded interface to ensure a secure andleak-free connection to other accessories. In another embodiment, thepressure sensor can be mounted near or at the distal end of the outertubular member to make a more direct measurement of blood pressure. Thisovercomes any deleterious dampening effects from trying to measurepressure through a small lumen in a catheter. In other words, thepressure signal weakens over distance making the signal to noise ratioworse. In another embodiment a dedicated lumen may be incorporated intothe space between the outer and inner tubular member to provide achannel for blood to be in fluid communication with an external pressuresensor, the dedicated lumen reducing any pressure dampening effects thata small clearance between tubular members might create. In still anotherembodiment, a micro-electronic mechanical (MEMs) pressure sensor may beintegrated at the end of the outer tubular member to provide highfidelity pressure measurements.

An access port is attached to the proximal most portion of the innertubular member to enable delivery of other devices such as guidewires orfluid such as sterile saline. Alternatively, a pressure transducer or aseparate port engaged with a pressure transducer can be connected to theproximal port. The proximal port described may have a threaded interfaceto ensure a secure and leak-free connection to other accessories or tofluids.

The control handle can incorporate O-rings or other sealing means toseal the lumen of the outer catheter while still preserving its abilityto be slid over the inner elongate tubular member. The O-rings orsealing means can be incorporated into a housing that also serves toretract and, subsequently, advance the outer tubular member over theinner tubular member.

To enhance safety, the control handle is configured to retract the outertubular member, rather than extend the inner tubular member. This safetyfeature is provided to prevent injury within the left ventricle. Forexample, there are vulnerable structures such as papillary muscles,chordae tendineae, mitral valve leaflets, and others, that can bedamaged by inadvertent extension of the catheter.

Additional features of the presently disclosed methods and devices willbecome apparent from the following description and appended claims,taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of the invention in its initial configurationshowing an outer tubular member in an AL1 catheter tip configuration;

FIG. 2 is an illustration of the invention with an inner tubular memberforming a pigtail configuration at the distal end, extending from withinthe outer tubular member after manipulating the control handle to changethe tip shape;

FIG. 3 is an exploded-view illustration of the inner and outer tubularmembers in component form shown separated for clarity;

FIG. 4 is an exploded-view illustration of the control handle;

FIG. 5A is an alternative embodiment of the invention in initialconfiguration showing tip shape and handle position;

FIG. 5B is an alternative embodiment of the invention in secondconfiguration showing tip shape and handle position;

FIG. 6 is an illustration showing an alternative embodiment of a portionof the control handle;

FIG. 7 is an illustration showing an alternative embodiment of a controlhandle configuration with a spring-loaded detent system actuated by adepressible release button;

FIG. 8 is an illustration showing an alternative embodiment of a controlhandle with undulations on the outer surface of the circular controlring;

FIG. 9 is a cross sectional illustration showing a view of the controlhandle, where dashed lines depict a fluid flow path from a side port;

FIGS. 10 A/B/C/D/E show the invention in the anatomy in variousconfigurations;

FIG. 11 is an illustration of the invention shown with a view of theslot in the control handle mechanism that limits movement of the outertubular member; and

FIG. 12 is a flowchart diagram of a method for employing the disclosedcatheter system shown in FIGS. 1-11.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following discussion of the embodiments of the disclosure directedto an aortic valve no exchange catheter system is merely exemplary innature, and is in no way intended to limit the disclosed techniques ortheir applications or uses.

Shown in FIG. 1 is the invention, which is a no exchange catheter system101 that benefits by reducing the need to remove and exchange variouscatheters and guidewires during a medical procedure. Shown in FIG. 2 isthe no exchange catheter system 101, comprised of an inner tubularmember 203 within an outer tubular member 103 each attached to separatecomponents of a control handle 105 approximately at their proximal ends.As discussed herein, the outer tubular member 103 is slidably extensibleand retractable over the inner tubular member 203, controlled by thecomponents of the control handle 105.

The inner tubular member 203 is longer than the outer tubular member103. In exemplary fashion, an inner tubular member 203 may have apigtail shape 205 at its distal end 206, and may be “5F” (meaning 5 onthe French scale, which equates to a diameter of 1.667 mm), and 110 cmlong. The outer tubular member 103 may have an AL1 (a particular type oftip) shape at its distal end 107, and can be 6F (2 mm diameter), and is90 cm long. Other lengths and diameters are contemplated. For example,the total catheter length can be 125 cm and the range of movement of theouter tubular member 103 over the inner tubular member 203 can be 12 cm.For transcatheter aortic valve replacement procedures, the standardguidewire length of 260 cm dictates the total catheter system length beless than 130 cm, and preferably close to 130 cm. Other tip shapes mayalso be used as best suited for a particular application.

The control handle 105, at the proximal end of the catheter system 101,has a circular control ring 109 to facilitate movement of the outertubular member 103. When the operator pulls back the outer tubularmember 103 via sliding the circular control ring 109 back on the controlhandle 105, the distal end of the inner tubular member 203 is exposedand forms a pigtail shape when fully extended from the outer tubularmember 103. The linear range of motion of the outer tubular member 103can be 10 to 20 cm. Other distal inner tubular member shapes arecontemplated and can be similarly exposed when the outer tubular member103 is retracted. Likewise, the range of linear travel for the outertubular member 103 can be optimized for other contemplated applicationssuch as converting a Judkins left catheter to a Judkins right catheterand utilizing a range of travel that is less than 10 cm. Alternatively,other applications may dictate a larger than 20 cm range of travel.

By design, the control handle 105 limits travel of the circular controlring 109 and thus the travel of the outer tubular member 103 over theinner tubular member 203. This is controlled in one embodiment by thedimensions of a slot 1101 in the control handle 105 as shown in FIG. 11.In some embodiments of the invention, a control ring locking feature isused to temporarily fix the position of the outer tubular member 103relative to the inner tubular member 203, where the catheter shape canbe locked into position only when the outer tubular member 103 is fullyextended or fully retracted. Referring to FIG. 6, a slot segment 607extending 90 degrees from a longitudinal travel slot 601 is provided toimmobilize a circular control ring 603 at the extreme limit of thecircular control ring travel. The circular control ring 603 performs thesame function as the circular control ring 109—that is, controls theposition of the outer tubular member 103 relative to the inner tubularmember 203. When at either of two extreme positions, the circularcontrol ring 603 can be rotated to lock the position of the catheter. InFIG. 6, the control ring 603 covers another of the slot segments 607which is at the distal end of the longitudinal slot 601. Alternatively,the slot 1101 of FIG. 11 or a hard stop (not shown) built into thehandle can preclude axial movement, forward and backwards, in place of atwist lock mechanism.

The circular control ring 603 is shown in FIG. 6 as having a knurledouter surface. FIG. 8 shows a control ring with outward facingundulations 801 or other features designed to enhance grip for operatorswearing gloves.

FIG. 1 depicts the device in the initial configuration, shown here as anAmplatzer AL1 tip shape. Alternatively, the shape of the distal segmentmay be that of an Amplatzer AL2 or any other shape an operator prefersto gain access to a particular area of the anatomy. The outer tubularmember 103 has been extended to cover the distal end of the innertubular member 203 (thus the inner tubular member 203 is not visible inFIG. 1), and the distal tips of the inner tubular member 203 and outertubular member 203 are aligned. In this position, the distal shape ofthe catheter is governed by the shape of the outer tubular member 103. Aluer 111 is fused to the proximal most edge of the inner tubular member203, thereby allowing a fluidic coupling to the proximal end of theinner tubular member 203. The fluidic coupling provided by the luer 111may be used to monitor pressure in the inner tubular member 203, ordeliver a fluid through the inner tubular member 203, for example. InFIG. 1, the circular control ring 109 is in its distal most position,relative to the handle 105; this position of the circular control ring109 is what causes the outer tubular member 103 to be fully extendedover the inner tubular member 203.

A side port assembly 113 is attached to the circular control ring 109and is able to fluidly communicate with the space between the innertubular member 203 and the outer tubular member 103, regardless of theposition of the circular control ring 109. The fluid communication spaceis sealed using O-rings or other sealing means, discussed below. TheO-rings are designed to slide along with the circular control ring 109.

FIG. 2 depicts the device with the pigtail section 205 shown at thedistal end 206 of the inner tubular member 203. In this configuration,the outer tubular member 103 has been fully retracted to expose thedistal end of the inner tubular member 203. The inner tubular member 203can be longer than the outer tubular member 103. Hence, in thisconfiguration of FIG. 2, a section of the inner tubular member 203 isextended from the outer tubular member 103. The circular control ring109 is in its proximal most position in this configuration, which iswhat caused the outer tubular member 103 to retract and expose theportion of the inner tubular member 203. A distal tip 106 of the outertubular member 103 is denoted on FIG. 2; this is the point at which theinner tubular member 203 emerges from the outer tubular member 103.

FIG. 3 depicts the inner tubular member 203 and the outer tubular member103 as separated, with each showing an exemplary tip shape. The innertubular member 203 is made from a relatively flexible polymericmaterial, one that conforms to the shape of the outer tubular member 103when inserted into the outer tubular member 103. The polymeric innertubular member 203 is made from a soft material such as a thermoplasticelastomer. One such soft material is a polyether block amide and has alow durometer value, for example, 35-55 Shore D. An example of thepolyether block amide is sold under the trademark PEBAX®. Other polymerssuch as thermoplastic polyurethanes with similar softness and similardurometer ranges are also contemplated. These materials are well knownto those skilled in the art. The wall of the inner tubular member 203 ismade deliberately thin, for example in a range of 0.003″ to 0.007″. Thepreferred wall thickness is approximately 0.005″. The thin wallthickness facilitates shape conformance of the inner tubular member 203to the outer tubular member 103.

The polymeric outer tubular member 103 is made from a relatively stiffermaterial than the inner tubular member 203. This can be accomplishedusing a higher durometer polymer, relative to the inner tubular member203. A polymeric material such as a polyether block amide in a range ofdurometers such as 55-76 Shore D are suitable. An example of thepolyether block amide is sold under the trademark PEBAX®. Other polymerssuch as thermoplastic polyurethanes with similar softness and similardurometer ranges are also contemplated.

The stiffness of the individual tubular members can be varied using oneor more of several techniques including selecting and/or mixing polymersof differing hardness, adjusting the tubing wall thickness,incorporating a stainless steel braid reinforcement, and/or using amulti-layer tubing design.

Typical intravascular catheters can be comprised of two sections, namelya proximal and distal section. These two sections are fused together toform one complete catheter. However, each section is designed to performa different function. For example, the first, or proximal section, tendsto be straight and stiff to enable advancement of the catheter to atarget region. The second, or distal section, is typically softer andshaped to engage the anatomy. It is a common practice to utilizedifferent stiffness grades of the same basic polymer material tofabricate the proximal and distal segments of each tubular member.

The inner tubular member 203 of this invention is comprised of a firstsection 221 and a second section 222, wherein the first section 221 is agenerally elongated straight section which is connected at its distalend with the second section 222, which is a curved section such as apigtail configuration.

Similarly, the outer tubular member 103 of this invention is comprisedof a first section 121 and a second section 122, wherein the firstsection 121 is a generally elongated straight section which is connectedat its distal end with the second section 122 that forms a compoundcurve designed to easily access the aortic valve and provide passage tothe left ventricle. An example of a distal shape may be an AmplatzerAL1.

FIG. 4 shows the major components of the control handle assembly in anexploded view. In short, the handle assembly provides for a slidable andleak free outer tubular member 103 configured to slide over a reinforcedinner tubular member 203. The outer tubular member 103 is attached to acontrol handle mechanism enabling the operator to retract or advance theouter tubular member 103. A distal end 401 of the inner tubular member203 may be inserted through the handle components for assembly. Astainless steel hypotube 402 is inserted over the inner tubular member203, is used to reinforce the inner tubular member 203, and functions toprevent unwanted bending or kinking of the inner tubular member 203during handle manipulation.

A sealing means such as an O-ring, a plurality of O-rings, or ahemostasis valve, adapted for sliding along a stiff, reinforcing memberenables relative movement of the inner tubular member 203 and outertubular member 103 while continuously providing a blood hemostasis seal.O-rings 403 are used to seal the proximal most portion 410 of the outertubular member 103, which in turn, is fused to a flexible slider tube405. This ensures a leak free system enabling the inner tubular member203 and the outer tubular member 103 to be slidable in relation to eachother.

A main body 404 within the circular control ring houses the O-rings 403and provides for a sealed fluid path (dashed line in FIG. 9) from theproximal segment 410 of the outer tubular member 103 to the side port408. A flexible slider tube 405 is inserted into the proximal segment410 of the outer tubular member 103. This enables the distal end 401 ofthe inner tubular member 203 and the stainless steel hypotube 402 to fitwithin the flexible slider tube 405. An adhesive bond with an adhesivefillet 411 provides a leak-free seal between the flexible slider tube405 and the proximal segment 410 of the outer tubular member 103 afterassembly.

The control handle mechanism housing 406 has a slot (FIG. 11, 1101)providing a fixed range of travel for the control ring 109. The controlhandle mechanism housing 406 is made in two halves, which when assembledare joined using adhesive or fasteners. The control handle mechanismhousing 406 houses the distal end 401 of the inner tubular member 203and provides the operator with a feature to grip the catheter. A luer407 is bonded to the proximal end of the inner tubular member 203 andprovides a means to couple the inner tubular member 203 to accessoriessuch as a syringe or a Touhy Borst connector (not shown).

The circular control ring 413 (same as control ring 109) is assembledfrom two halves bonded together and provides the operator with an easyto grip surface to manipulate the position of the outer tubular member103. The circular control ring 109 attaches to the handle controlmechanism 105 as shown in FIG. 1. This assembly, in turn, houses O-rings403, an O-ring slider mid-body 414, and O-ring slider end cap 415, andmaintains the O-rings in position. Dowel pins 412 can be used to fastenthe circular control ring halves 413 together immobilizing thecomponents in the circular control ring 109. A side port tubing 409connects the side port 408 to the proximal segment 410 of the outertubular member 103, to enable a leak free fluid communication path fromthe side port 408 (or 113 in FIG. 1) to the outer tubular member 103.

FIG. 9 is a cross-sectional illustration of the control handle assemblyshowing many of the same elements as FIG. 4. The following discussion isprovided to summarize the operation of the tubular members and thecontrol handle assembly as depicted in FIGS. 1, 2, 4 and 9. The keypoint is that the inner tubular member 203 is fixed relative to thecontrol handle 105, while the outer tubular member 103 slides relativeto the inner tubular member 203 based on movement of the control ring109 along the control handle 105 (FIGS. 1 & 2). After assembly, theinner tubular member 203 is fixed in longitudinal position relative tothe control handle 105, which is embodied primarily in the two halves ofthe control handle mechanism housing 406. The hypotube 402 supports theinner tubular member 203 to prevent kinking, and the luer 407 allows afluidic coupling to the inside of the inner tubular member 203. Theouter tubular member 103 slides longitudinally relative to the innertubular member 203 and the control handle 105, driven by the position ofthe control ring 109, which is embodied primarily in the circularcontrol ring halves 413 and the control ring main body 404. The flexibleslider tube 405 transfers motion of the control ring 109 to the outertubular member 103 itself. The flexible slider tube 405 slides over thehypotube 402 within the handle assembly. The annular space between theinner tubular member 203 and the outer tubular member 103 is in fluidcommunication with the side port tubing 409 and the side port 408, asshown in FIGS. 4 and 9.

FIG. 5a shows a depiction of an embodiment of the currently disclosedcatheter system in an initial configuration and FIG. 5b shows the samecatheter system in a second configuration. FIGS. 5-8 depict differentembodiments than the figures discussed previously, where in particular,the embodiments of FIGS. 5-8 include handle features for locking theextension/retraction position of the outer tubular member 103 relativeto the inner tubular member 203, but do not include a side port. FIGS. 5a/b include a control handle 605 and a control ring 603. As in earlierembodiments, longitudinal motion of the control ring 603 along thehandle 605 moves the outer tubular member 103 relative to the innertubular member 203. The position of the control ring 603 is shown inboth an initial configuration (FIG. 5a , where the outer tubular member103 is fully extended over and covers the inner tubular member 203) anda second configuration (FIG. 5b , where the control ring 603 and theouter tubular member 103 have been retracted, exposing the pigtail 205at the distal end 206 of the inner tubular member 203). The position ofthe control ring 603 controls the exposed amount of the inner tubularmember 203, which in turn correlates to the configuration of thecatheter tip, thus providing a visual cue to the operator of the distaltip configuration.

FIG. 6 shows the control handle 605 detached from the catheter. In thisembodiment of the control handle mechanism, the range of travel isdictated by a slot 601 in the handle housing. The slot 601 may include alocking feature, a slot segment 607 extending 90 degrees from thelongitudinal travel slot 601, at the proximal and distal (not shown)extremes of travel to provide for a twist lock mechanism to immobilizethe circular control ring 603 and thus preventing unwanted catheter tipshape changes.

FIG. 7 shows a control handle 705 which includes a spring-loaded detentsystem actuated by a depressible release button 703 that may provideadditional means to lock the catheter into position. The button 703 is acontrol element which replaces the control ring 603 of FIG. 6, and theouter tubular member 103 is attached to the button 703 for adjustment ofthe position of the outer tubular member 103. The button 703, whenpressed, may move along a slot 704. Releasing the button 703 locks thebutton 703 in place, which locks the position of the outer tubularmember 103 relative to the inner tubular member 203.

FIG. 8 shows the handle 605 with undulations 801 on the outer surface ofthe control ring 603, rather than the knurled surface of FIG. 6, toenhance the grip of the operator. The arrows in FIG. 8 depict thelongitudinal travel of the control ring 603 relative to the handle 605,and rotation of the control ring 603 into the slots 607 at either end ofthe range of travel.

The handle embodiments of FIGS. 6-8 are shown to illustrate the outertubular member 103 adjustment and locking features. For the sake ofclarity and simplicity, these handle embodiments are not shown withadditional features such as the side port 113 and the luer 111 of FIG.1—but the side port and luer features are equally applicable to any andall handle embodiments, including those of FIGS. 6-8.

FIGS. 10a-10e show the presently disclosed catheter system 101 in thehuman anatomy in various stages of insertion and the correspondingcatheter configuration. FIG. 10a shows the catheter system 101 beinginserted into an artery remote from the heart, such as in the upper leg.The lengths of the outer tubular member 103 and inner tubular member 203discussed previously are suitable for the catheter system 101 totraverse an artery all the way up to and into the heart.

FIG. 10b shows the catheter system 101 near a stenotic aortic valve ofthe heart. The distal end 107 of the outer tubular member 103, in an AL1configuration, is visible with a guidewire 1002 extending from the outertubular member 103. In FIG. 10b , the catheter system 101 has beeninserted through the vasculature up to the aortic valve of the heart,and the outer tubular member 103 is still fully covering the innertubular member 203, corresponding to the position of the control ring109 at the distal end of the control handle 105. The guidewire 1002 isnext used to guide the catheter system 101 through (across) the aorticvalve into the ventricle. A plurality of holes 1050 may be providedthrough the wall of the outer tubular member 103 near its distal end107, where the holes 1050 facilitate improved fluid communication to theproximal (handle) end of the outer tubular member 103 and thereforebetter measurement of pressure and/or better flow of fluids through thecatheter system 101.

FIG. 10c shows the catheter system 101 in the left ventricle. In thisfigure, the outer tubular member 103 is still fully covering the innertubular member 203, as the position of the control ring 109 is still atthe distal end of the control handle 105. The distal end 107 of theouter tubular member 103 remains in AL1 configuration and is now in itsdesired location in the ventricular chamber, where the holes 1050facilitate blood pressure measurement by a sensor at the proximal end ofthe outer tubular member 103 (discussed below). FIG. 10c represents thestage in the procedure where the catheter system 101 has been insertedinto position with the gently curved tip shape of the outer tubularmember 103, the guidewire 1002 has been retracted, and the procedureinvolving the inner tubular member 203 is ready to begin.

FIG. 10d shows the catheter system 101 being transformed from an AL1configuration to a pigtail configuration by beginning retraction of theouter tubular member 103. It can be seen in FIG. 10d that the controlring 109 has been moved over halfway toward the proximal end of thecontrol handle 105, which causes the outer tubular member 103 to retractand expose part of the inner tubular member 203. The pigtail shape 205is now visible at the distal end 206 of the inner tubular member 203. Aplurality of holes 1060 may be provided through the wall of the innertubular member 203 near its distal end 206, where the holes 1060facilitate improved fluid communication to the proximal (handle) end ofthe inner tubular member 203 and therefore better measurement ofpressure and/or better flow of fluids through the catheter system 101.

FIG. 10e shows the catheter system 101 with the outer tubular member 103fully retracted back up above the aortic valve. It can be seen in FIG.10e that the control ring 109 has been moved all the way to the proximalend of the control handle 105, which has caused the outer tubular member103 to fully retract and expose a maximum amount of the inner tubularmember 203. The holes 1050 in the outer tubular member 103 are visibleabove the aortic valve, where they improve fluid communication betweenthe aortic location and the proximal end of the catheter system 101. Theholes 1060 in the inner tubular member 203 are visible in the leftventricle, where they improve fluid communication between theventricular location and the proximal end of the catheter system 101.

FIG. 10e also shows a pressure transducer 1012 mounted at the side port113, and a pressure transducer 1022 mounted at the luer 111 tofacilitate differential blood pressure measurements, and an insetshowing the pressure measurement as it might appear on a viewinginstrument. Recall that the luer 111 is in fluid communication with theinside of the inner tubular member 203, and the side port 113 is influid communication with the annular space between the outer tubularmember 103 and the inner tubular member 203. Thus, the pressuretransducer 1012 is measuring pressure at the tip of the outer tubularmember 103 above the aortic valve, and the pressure transducer 1022 ismeasuring pressure at the tip of the inner tubular member 203 in theventricular chamber. The transducer 1012 provides a signal to thedisplay 1030 via wire 1014, and the transducer 1022 provides a signal tothe display 1030 via wire 1024. Alternatively, the transducers maycommunicate wirelessly with the display and any related computermonitoring system.

FIG. 10e also shows a fluid tube 1010 passing through the pressuretransducer 1012 and a fluid tube 1020 passing through the pressuretransducer 1022. The fluid tube 1010 is connected to the side port 113and could be used to introduce a fluid to or withdraw a fluid from thetip of the outer tubular member 103, which in this case is above theaortic valve. The fluid tube 1020 is connected to the luer 111 and couldbe used to introduce a fluid to or withdraw a fluid from the tip of theinner tubular member 203, which in this case is in the ventricularchamber. Techniques are used to prevent air embolization in the bloodstream and air in the tubes 1010 and 1020.

Rather than the transducers 1012 and 1022 to measure blood pressure asshown in FIG. 10, the catheter system 101 may include a sensor mountednear the distal tip of the outer tubular member 103 and/or the innertubular member 203 to monitor blood pressure (not shown).

The inner tubular member 203 is comprised of a relatively stiff proximaltubular member that is adapted for the outer tubular member 103 to slideover it and have sufficient column strength to avoid buckling. Theproximal segment 221 of the inner tubular member 203 can be fused to amore flexible distal segment 222 by any number of means including heator adhesive bonding. The proximal segment 221 of the inner tubularmember 203 may be made of a braid reinforced polymer tubing capable ofwithstanding high internal pressures without failure. This facilitatesthe use of a pressure injection system for radiopaque contrast injectioninto the heart for imaging. The proximal segment 221 of the innertubular member 203 may be made from a stiffer material such as 304stainless steel or a reinforced polyimide tube. Alternatively, the innertubular member proximal segment 221 could have a reinforcing sleeve toprovide needed stiffness.

The diameter dimensions of the invention at its proximal end, where itis reinforced or stiffened, can be different than the diameterdimensions, both inner and outer diameters, of the distal segment 222that enters into the patient or body.

The outer tubular member 103 similarly has a relatively stiffer proximalsegment 121 and a more flexible distal segment 122. The proximal segment121 is designed to withstand buckling as it is advanced and retractedover the outer diameter of the inner tubular member 203. Similar to theinner tubular member 203, the inner and outer diameter dimensions of thedistal segment 122 that enters into the body may differ from the portionthat interacts with or is in the handle control mechanism.

The catheter system 101 may come in two lengths, such as a standard 100cm, and a longer 125 cm catheter. Once the sterile catheter system isremoved from the sterile packaging, a 150 cm J-tipped guidewire can beinserted into the catheter system 101 (through the interior of the innertubular member 203) to allow placement of the catheter close to theaortic valve. Once in place, the 150 cm guidewire is removed and astandard 150 cm straight tipped guidewire is placed through the port orluer 111 attached to the base (proximal end) of the handle 105. Thisport or luer 111 can also enable measurement of left ventricularpressures as discussed above. This is accomplished by attaching anexternal pressure transducer to this port or, alternatively,incorporating a MEMs or optical pressure sensor into the catheter influid communication with the lumen connected to this port.

A second port, the sliding side port 113, is attached to the handleslide mechanism at the control ring 109 and is in fluid communicationwith the outer tubular member 103. This side port 113 enables the outertubular member 103 to be flushed with sterile saline or other fluidsthrough the lumen of the outer tubular member 103 (AL shaped catheter).This port also enables measurement of aortic pressures through the lumenof the outer tubular member 103 or AL shaped catheter. In yet anotherembodiment, additional side holes may be placed in the outer tubularmember 103 to facilitate more accurate, or less damped, pressuremeasurements.

Another application of the invention is for radial PCI. This embodimentprovides a single device that could safely, and predictably, be used inplace of multiple devices for performing invasive radial angiography.The control handle mechanism converts the shape of the catheter distaltip from one shape to another to perform as a diagnostic catheter forangiography and then safely permit the outer tubular member 103 to beretracted to expose the inner tubular member 203 to safely performcontralateral vessel angiography. In this respect, the control handlemechanism is similar to the transcatheter aortic valve application,although the method of use may vary between procedures. Advantageously,this configuration enables an initial tip configuration to safelynavigate through the body's vasculature system. When at the targetlocation, then the tip can be transformed to a more aggressive shape, tomore optimally perform the procedure in the coronary arteries. The moreaggressive tip shape of the inner tubular member 203, which may bewildly contoured and capable of causing injury during delivery, issheathed by a more safely shaped outer tubular member 103 until thedevice is advanced to the treatment zone. The risk of injury is reducedbecause a safer shape is maintained during delivery.

An alternative embodiment for this invention is for use ininterventional cardiology procedures, such as PCIs, where devices areinserted into occluded coronary arteries to reopen them and to provideblood to the heart. In difficult cases, known in the field as complexPCI, extra support is often needed to prevent the guide catheter frombacking out of the artery to be treated. In these situations whereadditional support is needed to deliver either a PTCA balloon or acoronary stent to the target lesion, the inner tubular member 203 isconfigured to be able to extend from within the outer tubular member 103into the coronary arteries. The current invention enables thiscapability faster and easier than the current approach of using multipledevices that require exchanges. In this embodiment, the outer tubularmember 103 would replace the function of a standard guide catheter,which typically is placed near the ostium of the vessel to be treated.The inner tubular member 203 is extended from the outer tubular member103 and is then advanced into the coronary artery to provide extrasupport. In these procedures, frequent catheter manipulations, includingrotating the device, makes it advantageous for the extended innertubular member 203 to be collapsed so it resides inside the handlecontrol mechanism. This eliminates the proximal segment from extendingover the hands of the operator and flopping around during devicemanipulation.

The previously described control handle mechanism can be used in thisapplication but the movement of the outer catheter would be in theopposite direction. The inner tubular member 203 is attached to andadvanced by the control handle mechanism to extend past the outertubular member 103. A handle embodiment may include provisions to enablea telescoping feature of the handle. This enables an original totalcatheter length (inner tubular member 203 and outer tubular member 103)that is desirably short for this procedure, for example 90 cm long. Whenutilizing the telescoping feature for the handle, the inner tubularmember 203 assembly is configured so that the telescoping handle can beinitially extended proximally (towards the operator and away from thepatient); then, during the procedure, the telescoping sections of thehandle can be collapsed, thus lengthening the inner tubular member 203so it may be extended past the outer tubular member 103. In a fullyextended position the device length can increase from 90 cm to 125 cm.There can be a means to limit the range of lengths of the inner tubularmember 203.

The telescoping feature can be comprised of multiple tubular membersdesigned to slide over each other in this handle embodiment. Eachtubular member has a specified diameter that enables it to be slidablypositioned over the underlying tubular member having a smaller diameter.There can be two such tubular members, which enable almost doubling thelength of the telescoping component of the handle. Additionally, morethan two tubular members may be employed in the same fashion to achievea greater change in length. The distal most tip of the telescopinghandle is attached to the proximal end of the catheter inner tubularmember 203. The attachment provides for a sealed lumen preventing a leakpath for air to enter into the body. A sealing means, such as O-rings,is used to ensure the telescoping handle mechanism is also sealed.

The described invention could be configured to have an inflatableballoon at its distal end to provide even more support. The balloon isattached to either the inner tubular member 203 or the outer tubularmember 103. Two balloons, one attached to each tubular member, is alsocontemplated. It is also advantageous to incorporate a discreteradiopaque marker component at the distal end of one or both of thetubular members 103/203 so that the operator knows the position of thetip of the catheter system 101 in the arterial anatomy. A radiopaquemarker may be made of platinum or a platinum alloy, such as 90% platinumand 10% iridium. There are other suitable radiopaque materials or alloysfor this function.

The invention may also have the inner tubular member 203 and the outertubular member 103 loaded, or filled, with a dense radiopaque materialto further improve visibility under fluoroscopy or x-ray systems. Inthis case, a material such as barium sulfate is added to the polymerswhich ultimately are extruded into tubular form. The ratio of theadditive to the parent tubing material may be 80% tubing material and20% radiopaque additive. Other ratios can be utilized to provideadequate imaging under fluoroscopy.

This embodiment of the invention would also allow the use of a buddywire system, which can be used for complex PCI. A buddy wire system iswhen an additional guidewire, is inserted along with the guidewirealready in place, is employed through the guide catheter to helpfacilitate the procedure by providing extra stability or an anchoringfunction.

This particular embodiment would allow less imaging contrast to be usedfor complex PCI because there are fewer device exchanges and the innertubular member 203 is of a smaller diameter lumen, which permits lesscontrast needed for visualization. Reducing the use of radiopaquecontrast for imaging is beneficial to the patient and the hospital staffin the catheter lab.

The present invention simplifies currently practiced procedures byallowing for fewer catheter and guidewire exchanges, thereby reducingrisk associated with the procedure. Outlined below are methods utilizingthe invention.

FIG. 12 is a flowchart diagram 1200 of a method for employing thedisclosed catheter system 101 shown in FIGS. 1-11. At box 1202, thecatheter system 101 is advanced with a preshaped tip, such as anAmplatzer 1 or AL1, through a puncture site into the vasculature, suchas the femoral artery, of a patient and to a target site of interest inthe body, such as the heart. The step at the box 1202, where the outertubular member 103 fully covers the inner tubular member 203, is shownin FIG. 10a discussed previously. Once the device is brought close tothe aortic valve through the arterial vasculature, at box 1204 thesurgeon's left hand (usually index finger and thumb) is used tostabilize the device by holding the control handle mechanism. Inaddition, the left hand can gently rotate the catheter clockwise orcounterclockwise in order to provide different angles for the distal end107 of the device to cross the stenotic aortic valve. Using the righthand, a straight tipped guidewire 1002, inserted through the Amplatzerlumen, is gently advanced and retracted until it is across the aorticvalve. FIG. 10b shows the actions of the box 1204.

Once the guidewire is across the aortic valve, at box 1206 the cathetersystem 101 is gently advanced into the left ventricle, the straighttipped guidewire 1002 is removed, and the proximal port 111 on thehandle 105 is flushed with sterile saline solution. An external pressuretransducer is then attached to the port 111 to make a pressuremeasurement. FIG. 10c shows the actions of the box 1206. At box 1208,holding the control handle 105 with the right hand, the left hand ismoved to the handle sliding control ring 109. The right hand is in afixed position (usually the entire right hand), and the left hand (indexfinger and thumb) pulls the control ring 109 proximally towards theright hand. Once the handle sliding control ring is fully moved towardsthe right hand, then the outer tubular member 103, for example the AL1shaped catheter, is pulled back and exposes the inner tubular member203, which can be shaped like a pigtail catheter. FIG. 10d shows theouter tubular member 103 partially retracted, and FIG. 10e shows theouter tubular member 103 fully retracted by the movement of the controlring 105 performed at the box 1208.

In this configuration, simultaneous pressure measurements can be made byattaching a second pressure transducer to the side port, which is doneafter appropriate flushing. For example, differential pressure readingsbetween the left ventricle and aorta can be made by two externaltransducers, as described above, attached to each of the two ports onthe present invention which interrogate each of the two lumens withinthe device, respectively. Each of the pressure transducers isinterrogating separate places in the body, for example, in this case theleft ventricle and the aorta. At box 1210, shown in FIG. 10e , thecatheter system 101 is in position, with the inner tubular member 203exposed and in position in the left ventricle, and pressure monitorsoperational. At this point, catheter placement has been completed andthe patient procedure (such as a TAVR or a PCI) may be performed.

Using an alternative embodiment, shown in the handle 605 of FIGS. 6 and8, once in the left ventricle, a control ring mechanism is rotated tounlock the inner tubular member 203 and outer tubular member 103 from afixed relative position. The operator retracts the ring along a definedlongitudinal length moving the ring from one extreme position to theopposite extreme position by moving the control ring mechanism. A hardphysical stop prevents movement beyond the defined extreme positions.These two extreme positions of the control ring mechanism correlate withconversion of the catheter tip configuration from one preset shaped to asecond preset shape, by retracting the outer tubular member 103 andexposing the inner tubular member 203 distal end. In the handleembodiment of FIG. 7, a push button is used to lock/unlock the controlhandle configuration.

In the methods discussed above according to this aspect of theinvention, the user desirably positions the device easily, safely, andquickly within the left ventricle. The ability to use an initial tipconfiguration (of the outer tubular member 103) for advancement of thecatheter system into the ventricle, and a second tip configuration (ofthe inner tubular member 203) during performance of the procedure oncein place, provides protection against injury to the arteries or theheart wall. The method desirably further includes the step of completingthis shape change without the operator having to look directly at thehandle mechanism. Methods according to this aspect of the inventionafford advantages similar to those discussed above in connection withthe apparatus.

In addition, this catheter can then be used for safe placement of thestiff wire for balloon valvuloplasty and transcatheter aortic valvereplacement procedures. A stiff guidewire needed to appropriatelystabilize and position the valvuloplasty balloon catheter can beinserted into presently disclosed inner tubular member 203 andpositioned as desired. The operator would then remove the cathetersystem 101 while maintaining position of the stiff guidewire. Once thecatheter system 101 is fully removed from the guidewire, a valvuloplastyballoon or transcatheter aortic valve can be inserted over the guidewireinto position within the anatomy.

It is anticipated that the disclosed invention with its quick cathetertip shape change capability can be applied to other applications thatbenefit from the need to reduce device exchanges or procedure time. Forexample, in radial PCI procedures, there is a desire to minimize deviceexchanges in delicate arteries in the arm. Radial procedures offerpatient benefits over traditional femoral artery approaches, reducedrecovery time, and fewer access site bleeding complications. Publishedclinical literature has shown mortality benefits using the radial accessapproach over the more traditional femoral artery approach.Consequently, the use of radial access PCI procedures have supplantedfemoral artery PCI in many labs throughout the world. In addition, manyother applications for the disclosed device are envisioned—includingapplications in the fields of neurology, urology, and peripheralvascular procedures.

While a number of exemplary aspects and embodiments for a rapid cathetertip shape change handle control system have been discussed above, thoseof skill in the art will recognize modifications, permutations,additions and sub-combinations thereof. It is therefore intended thatthe following appended claims and claims hereafter introduced areinterpreted to include all such modifications, permutations, additionsand sub-combinations as are within their true spirit and scope.

What is claimed is:
 1. A concentric two-tube catheter device, saiddevice comprising: an inner tubular member having a proximal endattached to a handle body and a distal end with a tip shape configuredfor a particular medical procedure; an outer tubular member concentricwith and slidably disposed upon the inner tubular member, said outertubular member having a proximal end attached to a control ring, and atip shape configured for placement of the catheter device in a patient;a handle assembly comprising the handle body and the control ring, wherethe control ring is slidably disposed upon the handle body, and wherepositioning the control ring at a distal end of the handle body causesthe outer tubular member to be fully extended and fully cover the innertubular member, and positioning the control ring at a proximal end ofthe handle body causes the outer tubular member to be retracted andexpose the distal end of the inner tubular member; and a side portdirectly attached to the control ring and configured to slide in unisonwith the control ring relative to the handle body, the side port influid communication with an annular space between the outer tubularmember and the inner tubular member, and an end port coupled to aproximal end of the handle body and in fluid communication with aninterior of the inner tubular member; where the outer tubular member hasa bending stiffness greater than that of the inner tubular member,causing the tip shape of the inner tubular member to conform to the tipshape of the outer tubular member when the inner tubular member is fullycovered by the outer tubular member.
 2. The device according to claim 1further comprising a first pressure transducer coupled to the end portand configured to monitor a pressure at the distal end of the innertubular member, and a second pressure transducer coupled to the sideport and configured to monitor a pressure at the distal end of the outertubular member, where the first and second pressure transducers providesignals to a display device for visual display.
 3. The device accordingto claim 1 further comprising a first fluid line coupled to the endport, and a second fluid line coupled to the side port, where the firstand second fluid lines are adapted to provide fluids to, or withdrawfluids from, the distal ends of the inner tubular member and the outertubular member, respectively.
 4. The device according to claim 1 whereinthe inner tubular member and the end port are adapted to permit a guidewire to be inserted into the end port and advanced to and through thedistal end of the inner tubular member.
 5. The device according to claim1 further comprising a stainless steel hypotube concentricallysurrounding the proximal end of the inner tubular member inside thehandle body, and a flexible slider tube coupling the proximal end of theouter tubular member to the control ring, where the flexible slider tubeconcentrically surrounds and is slidable relative to the hypotube. 6.The device according to claim 1 wherein the inner tubular member or theouter tubular member, or both, has a plurality of holes formed through atube wall near its distal end.
 7. The device according to claim 1further comprising a slot in the handle body configured to define limitsof travel of the control ring, wherein a distal end of the slotcorresponds to a control ring position which causes the outer tubularmember to be extended to a position fully covering the distal end of theinner tubular member, and a proximal end of the slot corresponds to acontrol ring position which retracts the outer tubular member andexposes a maximum desired length of the distal end of the inner tubularmember.
 8. The device according to claim 6 further comprising a lockingfeature in the handle body which allows locking the control ring inposition relative to the handle body.
 9. The device according to claim 8wherein the locking feature is a slot segment at each end of the slot,where the slot segments are oriented perpendicular to the slot and allowthe control ring to be rotated into a locked position.
 10. The deviceaccording to claim 1 wherein a radiopaque material is provided in aportion of the inner tubular member or the outer tubular member or both,where the radiopaque material improves visibility of the device underfluoroscopy or x-ray.
 11. The device according to claim 1 wherein theinner tubular member and the outer tubular member are each comprised ofa proximal segment and a distal segment, where the proximal segment ofeach tubular member has a greater bending stiffness than that of thedistal segment of the same tubular member.
 12. The device according toclaim 1 wherein the tip shape of the outer tubular member is a hookshape configured for advancing the outer tubular member to and across anaortic valve of a patient's heart, and the tip shape of the innertubular member is a pigtail shape configured for performing a procedurein a ventricle of the heart.
 13. A concentric two-tube catheter device,said device comprising: an inner tubular member having a proximal endattached to a handle body and a distal end with a tip shape configuredfor a particular medical procedure; an outer tubular member concentricwith and slidably disposed upon the inner tubular member, said outertubular member having a proximal end attached to a control element, anda tip shape configured for placement of the catheter device in apatient; a handle assembly comprising the handle body and the controlelement, where the control element is slidably disposed within a slot inthe handle body, and where positioning the control element at a distalend of the handle body causes the outer tubular member to be fullyextended and fully cover the inner tubular member, and positioning thecontrol element at a proximal end of the handle body causes the outertubular member to be retracted and expose the distal end of the innertubular member; a side port directly attached to the control element andconfigured to slide in unison with the control element relative to thehandle body, the side port in fluid communication with an annular spacebetween the outer tubular member and the inner tubular member; and anend port coupled to a proximal end of the handle body and in fluidcommunication with an interior of the inner tubular member.
 14. Thedevice according to claim 13 further comprising a first pressuretransducer coupled to the end port and configured to monitor a pressureat the distal end of the inner tubular member, and a second pressuretransducer coupled to the side port and configured to monitor a pressureat the distal end of the outer tubular member, where the first andsecond pressure transducers provide signals to a display device forvisual display.
 15. The device according to claim 13 further comprisinga locking feature in the handle assembly, where the locking featureallows the control element to be locked in position relative to thehandle body.
 16. The device according to claim 15 wherein the lockingfeature is a slot segment at each end of the slot in the handle body,where the slot segments are oriented perpendicular to the slot and allowthe control element to be rotated into a locked position.
 17. The deviceaccording to claim 15 wherein the locking feature is a push button onthe control element, where depressing the push button allows the controlelement to be moved along the slot in the handle body, and releasing thepush button causes the control element to be locked in position relativeto the handle body.
 18. A dual-catheter device comprising an innertubular member, an outer tubular member concentric with and slidablydisposed upon the inner tubular member, a control handle assemblyincluding a handle body and a control element, and a side port directlyattached to the control element and configured to slide in unison withthe control element relative to the handle body, the side port in fluidcommunication with an annular space between the outer tubular member andthe inner tubular member, where sliding the control element along thehandle body causes the outer tubular member to be extended or retractedrelative to the inner tubular member.
 19. The device according to claim18 further comprising a locking feature in the handle assembly whichallows locking the control element in position relative to the handlebody.
 20. The device according to claim 1 wherein an O-ring is disposedbetween the control ring and the inner tubular member, the O-ringconfigured to seal an end of the annular space between the outer tubularmember and the inner tubular member, where the O-ring is configured toslide in unison with the control ring relative to the handle body tomaintain the seal during a sliding of the control ring relative to thehandle body.